1. Field of Invention
The present invention relates to the problems of urinary incontinence in women and more specifically to the problems of urinary stress incontinence. The invention relates more particularly to a percutaneous device for treating urinary stress incontinence in women using a sub-urethral tape.
2. Description of Related Art
These problems are currently treated during surgical interventions under local, regional or general anesthetic and consist in implanting a tape in such a way as to support the urethra without tension.
Thanks to the regional or local anesthesia, the surgeon can immediately check that continence has been restored, with the participation of the patient.
An intervention such as this is performed using an appropriate device including special instruments.
In particular, it is a known practice in treating urinary incontinence to use a tape that can be implanted under the urethral canal, and a sheath surrounding the tape, where the sheath is withdrawn from the tape after the latter has been implanted.
There is a known device for treating urinary stress incontinence in women, comprising:
a flexible and elongate urethra support means comprising a tape and a protective sheath lying flat and enveloping the tape, and
a puncturing needle with an active distal end and a proximal end connected to a first end of the flexible and elongate urethra support means.
Thus, U.S. Pat. No. 5,899,909 discloses a treatment method and a treatment device for incontinence. The device described, which allows a tape to be placed under the urethra, comprises two special needles. These are mounted in turn, by screw fastening, on a reusable steel insertion tool made of a handle and of a threaded manipulator rod which allows each of the needles to be manipulated in turn. Each needle is fixed to one of the ends of the tape-sheath assembly.
Each end of the tape-sheath assembly is fixed to a frustoconical part of one end of the corresponding needle, using a shrunk or bonded polymer ring.
The tape is therefore implanted by introducing each of the needles through a short incision in the anterior vaginal wall, these incisions being one on each side of the central position of the urethra.
The needles implanted in turn using the manipulator rod, then travel up around the bladder and the pubic bone and reemerge from the body through incisions made in the abdominal wall in the suprapubic region.
The two halves of the sheath which overlap at the middle of the tape are withdrawn by pulling on the ends that emerge from the suprapubic incisions.
A device such as this requires the use of ancillaries of the insertion handle and rigid intravesical catheter guide types especially designed for this type of surgical intervention.
The known surgical intervention also has a disadvantage insofar as the needles are introduced into the anterior wall of the vagina to reemerge in the suprapubic region. This bottom-upward path cannot be controlled precisely for going around the base of the bladder. Vesical perforations are far from uncommon. They need to be recognized preoperatively through the use of two cystoscopies and entail repeating the maneuvers under more difficult conditions.
The two accessories (manipulator handle and rigid probe guide) must therefore be available to the surgical team during each intervention, having been previously washed, packaged and sterilized prior to each use. In addition, this lateral passage with respect to the bladder, with a vaginal point of entry runs the risk that the point of the needle will injure the iliac vessels in the retrocrural region. These vascular lesions have been observed and have led to fatalities.
Another drawback of the known device lies in the difficulty of repeating the intervention, using the same device, when cystoscopy reveals that the sheath-tape assembly has taken the wrong course. Retreat may prove difficult and tricky for the sheath, and especially for the bulky needles.
The sheath-tape assembly has therefore to be cut and the device can no longer be used to take a different path. It also carries the risk of no longer being sterile as it may have been contaminated during these additional maneuvers.
Thus no percutaneous treatment exists for female urinary stress incontinence which uses a tape which can lead to the devices and technique of the present invention.
The present invention provides a device for treating urinary stress incontinence in women comprising a flexible and elongate mechanism comprising a tape for supporting a urethra and a flat protective sheath enveloping the tape; and a puncturing needle with an active distal end and a proximal end connected to a first end of the flexible and elongate mechanism, wherein the proximal end of the puncturing needle is connected to a first end of the flexible and elongate mechanism by an intermediate traction element, a second end of the flexible and elongate mechanism being free.
A method for treating urinary stress incontinence in a woman suffering from urinary stress incontinence is also provided by the present invention comprising (a) forming an opening in an anterior vaginal wall; (b) creating, from two small suprapubic incisions formed in the abdominal wall, a right track and a left track from the abdominal skin to the opening formed in the anterior vaginal wall; (c) using a needle and an intermediate traction element to follow one of the tracks and following the other track with at least a needle; (d) verifying by cystoscopy that the paths of the tracks are outside the bladder and the urethra; (e) using a support tape surrounded by a plastic sheath to follow the tracks by passage under an inferior surface of the urethra; (f) adjusting a loop formed by the sheathed tape under the inferior surface of the urethra; (g) removing the sheath by pulling the sheath toward the outside of the woman""s body through the small suprapubic incisions; and (h) leaving the tape implanted from the first to the second incision and around the urethra to support the urethra.
The object of the present invention is to overcome the drawbacks of the prior art so as to obtain a different operative technique which is easier, quicker and safer (as far as the bladder and vessels are concerned). The risk of vascular lesion is minimised because of the orientation and the given direction of the needle from the start of the procedure. The risk of vesical puncture is small even in the case of previous interventions in this regard, as is particularly frequent in this type of pathology. Using the device and operating method of the invention, the percutaneous route is used to form top-to-bottom tracks using the needle, i.e., penetrating via abdominal cutaneous mini-incisions to exit via a previously formed vaginal opening. Detachment of the vagina allows the index finger of the surgeon to be insinuated up to the lower rim of the pubis and thus enables the track of the needle to be precisely directed.
The device of the invention enables tracks to be made from top to bottom on both sides of the abdomen and enables the absence of vesical puncturing to be confirmed by cystoscopy before engaging the sheath-tape system. The present device makes it possible to employ the techniques that will be described in detail later on in this description.
Another object of the present invention is to produce a device for treating urinary incontinence which can be reused easily if it is introduced into the body in a non-optimum path, an eventuality which, according to the present invention, can occur only under exceptional circumstances if there is very strong adhesion between the bladder and the pubis, generally as the result of earlier interventions.
According to an embodiment of the invention, the proximal end of the puncturing needle is connected to the first end of the flexible means by virtue of an intermediate traction element, the second end of the flexible means being free or extended by an additional intermediate traction element.
According to one embodiment of the device according to the invention, the protective sheath completely envelopes the tape, including its first and second ends.
According to one embodiment of the invention, the sheath can be split into two parts that can be separated by sliding them in two opposite directions relative to the tape, the device comprising a splittable means between the two central and adjacent ends of the sheath.
According to another embodiment of the device according to the invention, the device comprises a filament arranged roughly at right angles to the longitudinal axis of the sheath, configured to cut the sheath when traction is exerted on the filament.
According to one embodiment of the device according to the invention, the sheath is made of a fluoropolymer-based heat-shrinkable material.
According to one embodiment of the device according to the invention, the tape is formed from a macroporous knitted material.
According to one embodiment of the invention, the tape in its central region has a resorbable hydrophilic film reducing the risk of adhesion to or the risk of erosion of the urethra.
According to one embodiment of the device according to the invention, the puncturing needle has a curved part continuously adjacent to a roughly straight part ending in its proximal end.
According to one embodiment of the invention, the intermediate traction element is a traction lace.
According to one embodiment, the device according to the invention comprises an end piece onto which the sheath is heat shrunk and to which the traction lace attaches.
According to one embodiment according to the invention, the traction lace has a length roughly equal to the length of the flexible means.
According to a preferred embodiment of the device according to the invention, the intermediate traction element is tubular.
According to one embodiment of the device according to the invention, the intermediate traction element and the puncturing needle are assembled by screwing.
According to one embodiment of the device according to the invention, the traction element consists of two parts of roughly the same length, placed end to end and joined together removably, for example by screwing, using a coupling.
According to one embodiment of the device according to the invention, the puncturing needle with an active distal end and a proximal end attached to a flexible and elongate means is the only puncturing needle.